Preventive Control Monitoring & Management Program
Compliant with 21 CFR §117.140–§117.145 — Monitoring, Corrective Actions & Verification
This program establishes a structured system for managing Preventive Controls, ensuring that all controls defined in your Food Safety Plan are consistently monitored, verified, and maintained in compliance with 21 CFR §117.140 and 21 CFR §117.145, while supporting the implementation of monitoring procedures, corrective actions, and verification systems required under Subpart C of the Food Safety Modernization Act (FSMA).
Program Objective
To develop and implement an integrated Preventive Control Management System that:
- • Ensures effectiveness of preventive controls across all operations
- • Establishes structured monitoring and documentation practices
- • Defines corrective action and correction procedures
- • Implements verification and validation systems
- • Maintains audit-ready records for FDA inspections and third-party audits
Deliverables
1. Preventive Control Management Plan
- • Identification of all applicable preventive controls requiring oversight
- • Classification of controls, including:
- ◦ Process controls (e.g., CCPs)
- ◦ Allergen controls
- ◦ Sanitation controls
- ◦ Supply-chain controls
- • Assignment of management components based on control type
2. Written Monitoring Procedures
- • Step-by-step monitoring procedures for each preventive control
- • Defined monitoring frequency, methods, and responsible personnel
- • Integration of exception-based recordkeeping where applicable (e.g., refrigeration logs)
3. Monitoring Records Templates
- • Custom logbooks or digital forms for routine monitoring activities
- • Templates designed for high-risk controls, including:
- ◦ Temperature monitoring
- ◦ pH and process parameters
- ◦ Cleaning and sanitation verification
- • Standardized formats for consistency and audit readiness
4. Corrective Actions & Corrections Framework
- • Clear distinction between corrections and corrective actions
- • Templates for documenting deviations, non-conformances, and product disposition
- • Procedures for root cause analysis, retraining, and preventive measures
- • Guidance for product hold, evaluation, and release decisions
5. Verification System
- • Scheduled review of monitoring records and corrective actions
- • Defined verification activities, including:
- ◦ Record review
- ◦ Calibration and validation checks
- ◦ Supply-chain verification (if applicable)
- • Documentation of verification outcomes and PCQI oversight
6. Exception Records Management
- • Implementation of affirmative or exception-based recordkeeping systems
- • Guidance on alternative documentation approaches for specific operations
- • Alignment with regulatory expectations for time/temperature control monitoring
7. Training: Preventive Control Oversight
- • Staff training modules on monitoring, documentation, and response procedures
- • SOP integration for consistent execution across teams
- • Competency assessments and training records for compliance tracking
Ongoing Program Support
- • Continuous review of monitoring and verification records
- • Periodic updates to training materials and compliance procedures
- • Guidance on corrective action implementation and effectiveness
- • Review of exception logs and supply-chain preventive control activities
- • Regulatory updates impacting preventive control requirements
- • Ongoing support for audit readiness and compliance inquiries
Ideal For
- • Facilities implementing or updating FSMA-compliant Food Safety Plans
- • Contract manufacturers aligning with HARPC and PCQI requirements
- • QA and Food Safety teams requiring structured monitoring systems
- • Operations handling high-risk or ready-to-eat (RTE) foods
- • Companies preparing for FDA inspections or third-party audits
Program Value
- • Ensures consistent execution and documentation of preventive controls
- • Strengthens compliance with FSMA monitoring and verification requirements
- • Reduces risk of control failure through structured oversight
- • Improves audit readiness with complete and traceable records
- • Supports continuous improvement of food safety systems
Fees and Subscriptions
Initial Setup Fees
| Plan | Description | One-Time Fee |
|---|---|---|
| Basic Monitoring Kit | Setup for 1 preventive control with forms & SOPs | $750 |
| Standard Oversight Package | Management plan for 3–5 controls | $1,950 |
| Comprehensive Facility Program | Full oversight of 6+ controls + audit prep | $3,500 |
Monthly Maintenance Fees
| Plan | Monthly Maintenance | Monthly Fee |
|---|---|---|
| Basic | Annual review support + quarterly record review | $200/month |
| Standard | Bi-monthly record review + email support + refresher updates | $450/month |
| Comprehensive | Monthly file review, retraining access, audit prep calls, and CAPA log reviews | $750/month |
Monthly Maintenance Coverage Includes
- • Ongoing recordkeeping compliance checks
- • Quarterly refresher training module updates
- • Corrective action guidance and feedback on implementation
- • Review of exception logs and supply-chain PC oversight
- • Email support for compliance questions and audit readiness
- • Alerts on regulatory updates impacting §117 Subpart C
Ideal For:
- • Facilities implementing or updating a FSMA-compliant food safety system
- • Contract manufacturers seeking to align with HARPC and PCQI best practices
- • QA Managers needing structured documentation for FDA or third-party audit readiness
- • Businesses managing high-risk or RTE foods requiring ongoing monitoring and proof of control
